Bag system for collecting and sampling a biological fluid

ABSTRACT

A bag system for the collection and sampling of a biological fluid such as blood is described. The system may include a fluid collection bag and a first tube connected on one end to a collection means and on the other end to the collecting bag. It may also include a flexible sampling bag defining an internal volume having a bottom side and an introduction side which is opposite to the bottom and has an inlet orifice. The system also has a second tube, a first end part of which is connected to the first tube and a second end part of which is inserted in the inlet orifice of the sampling bag, so as to extend inside the sampling bag over a distance of between 25% and 60% of the distance between the bottom and the introduction side of the internal volume of the sampling bag.

PRIORITY CLAIM

[0001] The present application claims priority under 35 U.S.C. §119(d)to French Application Ser. No. 0307493, filed Jun. 20, 2003.

FIELD OF THE INVENTION

[0002] The invention includes a bag system for collecting and sampling abiological fluid, such as blood or a blood component, taken from adonor.

BACKGROUND OF THE INVENTION

[0003] Certain bag systems may include a collecting bag intended toreceive the blood taken from a donor and intended for transfusion toanother person, and a sampling bag intended to receive the firstmillilitres of blood taken. Both bags are generally flexible, and areformed, for example, from two sheets connected to each other near theirperiphery.

[0004] A first tube is connected at a first end to a collection means,such as a phlebotomy needle intended to be inserted into the arm of thedonor, and at a second end to an inlet orifice of the collecting bag.

[0005] A second tube is connected at one end to the first tube and atthe other end to an inlet orifice of the sampling bag.

[0006] A closure system, such as a clamp, is placed on each of the twotubes and makes it possible to direct the blood donated to the samplingbag or to the collecting bag.

[0007] A lateral sampling device, connected outside the sampling bag tothe second tube, enables the blood contained in the sampling bag to bewithdrawn by means of vacuum tubes. The samples of blood thus obtainedare normally systematically analysed in order to determine the rhesusgroup, to make a count and to detect any contaminations such as viruses,bacteria or other undesirable elements present in the blood of thedonor, before transfusing the blood to another person.

[0008] Filling the sampling bag prior to the collecting bag presents acertain number of advantages and improves the quality of the samples andthe blood remaining for transfusion.

[0009] First, this reduces the risk of contamination of the bloodintended for transfusion. Such contamination often results from thepresence of bacteria or other foreign substances on the skin of thedonor. However, the first millilitres of blood taken, which are mostlikely to exhibit these foreign substances, are sent into the samplingbag rather than into the collecting bag, thereby greatly decreasing thechances of contamination of blood in the collecting bag.

[0010] Second, this arrangement makes it possible to take samples beforethe collecting bag is completely filled, and consequently save time.

[0011] Finally, during donation, the loss of blood volume for the donormay be compensated for by plasma. As a result, the hematocrit of thedonor blood may appear artificially lower if samples are taken after thecollection bag is filled.

[0012] Although this system has proven very beneficial, room forimprovement remains. In one such previous system, the end part of thesecond tube is inserted in the inlet orifice of the sampling bag butdoes not enter inside the bag, or it enters only a short distance.

[0013] This presents several drawbacks due to the fact that, when thesampling bag is placed so that its inlet orifice is situated towards thetop, the end of the second tube connected to the said inlet orifice issituated above the blood-air interface.

[0014] Thus, in the event of unintentional pressure on the sampling bag,the latter deforms because of its flexibility, and as a result part ofthe air contained in this bag rises in the tube. Because the samplingbag is connected to the collection means, there is a not insignificantrisk of gas embolism, that is to say entry of air into the venous systemof the donor. Additionally, it is known that an entry of air upstream ofthe heart may cause drainage of the heart pump and cardio-circulatoryarrest, which may sometimes lead to death of the donor.

[0015] Even in the absence of unintentional pressure on the samplingbag, this configuration is not entirely satisfactory because the failureof the second tube to be immersed in the blood contained in the samplingbag (when the bag is in the aforementioned position) renders itimpossible to fill tubes for analysis of the blood in the sampling bagwhile that bag is being filled. Instead, once the sampling bag isfilled, it must be turned over so that the inlet orifice is situateddownwards before samples may be removed by vacuum tube. This causes anundesired loss of time.

[0016] In another example of the previous sampling bag/collecting bagsystem, the end part of the second tube is inserted in the inlet orificeof the sampling bag and enters inside the bag, so that the correspondingend of the second tube is situated in the immediate vicinity of thebottom of the bag. This is in particular described in U.S. Pat. No.6,387,086. However, this arrangement is also not fully satisfactory.

[0017] Specifically, when the bag is oriented so that the end of thetube is situated downwards, the end is in contact with the blood ratherthan with air very soon after blood begins to enter the sampling bag,and the embolism problems encountered with the first embodiment may beavoided. However, it is desirable to be able to place and use thesampling bag in an inverted position, where the inlet orifice issituated not towards the top but towards the bottom. This places the endof the second tube above the blood and may allow air to enter it. Inthis case, the system of the document U.S. Pat. No. 6,387,086 poses thesame problems as those described above for the embodiment in which thesecond tube does not enter the sampling bag.

[0018] Moreover, in this version of the sampling bag system, the longerthe end part of the second tube situated inside the sampling bag, thegreater the volume of air contained in the said bag, before anycollection of blood for sampling. Specifically, the volume of air is thesum of:

[0019] the volume contained in the end part of the second tube situatedinside the sampling bag; and

[0020] the volume of air trapped around the second tube, over its entirelength, between the two sheets forming the sampling bag.

[0021] Thus, the greater the length of the end part of the second tubeinserted inside the bag, the greater the volume of air available to riseup in the tube as far as the vein of the donor. The risk of gas embolismis considerably increased thereby.

[0022] It is therefore particularly important to ensure that the volumeof air contained inside the bag before blood donation is initiated islimited to the maximum possible extent. This is particularly true whenair from a tube, such as the second tube, will be added to volume of airin the sampling bag after blood donation begins.

SUMMARY

[0023] The present invention overcomes the above or other problems withprevious bag systems having a sampling bag and a collecting bag.Specifically, the present invention prevents a large volume of air fromentering the vein of the donor from the bag system during donation orsignificantly limits the volume of air available to enter the vein ofthe donor. Further the present invention achieves this result regardlessof the position of the sampling bag during donation or the volume ofblood contained in the sampling bag.

[0024] In one embodiment, the invention includes a bag system for thecollection and sampling of a biological fluid, such as blood or a bloodcomponent, from a donor. The system includes a bag for collecting thefluid and a first tube connected at a first end to collection means,such as a phlebotomy needle, and, at a second end, to an inlet orificeof the collecting bag. It also includes a flexible sampling bag definingan internal volume, the internal volume having a side forming a bottomand an introduction side opposite to the said bottom, the introductionside having an inlet orifice. Finally, the system also includes a secondtube, a first end part of which is connected to the first tube at adistance from the first end of the s first tube, and a second end partof which is inserted in the inlet orifice of the sampling bag. Thesecond end part of the second tube extends inside the sampling bag overa distance lying between 25% and 60% of the distance between the bottomside and the introduction side of the internal volume of the samplingbag.

[0025] According to a specific embodiment, the second end part of thesecond tube extends inside the sampling bag over a distance of between30% and 50% of the distance between the bottom side and the introductionside of the internal volume of the sampling bag.

[0026] The bag system of some embodiments may also include a lateralsampling device connected, outside the sampling bag, to the second tube,and arranged to allow the sampling of at least part of the fluidcontained in the sampling bag.

[0027] The bag system in certain embodiments may also include a set ofsatellite bags connected, by means of at least one tube, to at least oneoutlet orifice of the collecting bag. For example, the set of satellitebags may include at least two bags and a filtration unit all arranged soas to allow the circulation of the fluid in closed circuit.

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Other objects and advantages of the invention will emerge duringthe following description given with reference to the accompanyingdrawings, in which:

[0029]FIG. 1 is a schematic representation, in elevation, of a bagsystem for collection and sampling a biological fluid, according to anembodiment of the present invention, having a sampling bag provided withan inlet orifice situated towards the top;

[0030]FIG. 2 is a representation similar to that in FIG. 1 with theinlet orifice of the sampling bag being situated towards the bottom;

[0031]FIG. 3 is a schematic representation, in elevation, of a bagsystem for collecting and sampling a biological fluid, according toanother embodiment of the present invention.

DETAILED DESCRIPTION

[0032]FIGS. 1 and 2 depict a bag system 1 for collecting and sampling abiological fluid, according to one embodiment of the present invention.System 1 includes a fluid collection bag 2, a first tube 3 connected ata first end to collection means 4, and at a second end to an inletorifice 6 of the collecting bag 2. A protector 5 for the collectionmeans 4 may be disposed on the said tube 3.

[0033] The system 1 also includes a flexible sampling bag 7 defining aninternal volume, the internal volume having a side 8 forming a bottomand an introduction side 9 opposite to the bottom side 8. Theintroduction side 9 has an inlet orifice 10.

[0034] The system 1 also includes a second tube 11, a first end part ofwhich is connected, by means of a three-way junction 12, to the firsttube 3, and a second end part of which is inserted in the inlet orifice10 in the sampling bag 7.

[0035] A lateral sampling device 13 is connected, outside the samplingbag 7, to the second tube 11, and arranged to allow the collection of atleast part of the fluid contained in the sampling bag 7. This lateralsampling device 13 enables the blood or other biological fluid containedin the sampling bag 7 to be collected in vacuum tubes.

[0036] Clamps 14, 15 may be placed respectively on the first 3 andsecond 11 tubesand make it possible to direct the blood withdrawn fromthe donor to the sampling bag 7 or to the collecting bag 2.

[0037]FIG. 3 depicts a bag system 1 for collecting and sampling abiological fluid, according to a second embodiment of the presentinvention. In order to perform filtration and separation steps as wellas the removal of leukocytes from the various constituents of the blood,the collecting bag 2 may be in fluid communication, by means of a thirdtube 16, with a satellite bag 17. A filtration unit 18 for leukocyteremoval may be situated between the collecting bag 2 and the satellitebag 17. The collecting bag 2 (and/or the satellite bag 17) may be influid communication with one or more other satellite bags 19 by means ofa fourth tube 20.

[0038] In various embodiments, the bag system 1 may be arranged so as toallow the circulation of the fluid in closed circuit.

[0039] In preferred embodiments, the second end part of the second tube11 extends inside the sampling bag 7 over a distance of between 25% and60% of the distance between the bottom 8 and the introduction side 9 ofthe internal volume of the sampling bag 7.

[0040] According to one possible embodiment, the second end part of thesecond tube 11 extends inside the sampling bag 7 over a distance ofbetween 30% and 50% of the distance between the bottom 8 and theintroduction side 9 of the internal volume of the sampling bag 7.

[0041] Thus the end part of the second tube 11 extends inside thesampling bag 7 over a sufficient distance. Because of this, when thesampling bag is used with its inlet orifice situated towards the top (asdepicted in FIG. 1), some time after donation begins, the end part ofthe second tube 11 is immersed in the fluid.

[0042] This makes it possible both to considerably limit the risks ofgas embolism in the donor following unintentional pressure exerted onthe sampling bag 7, and to allow the filling of tubes for analysis ofthe blood collected during the filling of the sampling bag itself oralter during the donation process.

[0043] Moreover, the end part of the second tube 11 does not extendinside the sampling bag 7 over too great a distance. Thus, when thesampling bag is used with its inlet orifice situated towards the bottom(as depicted in FIG. 2), some time after the donation begins, the endpart of the second tube 11 is immersed in the fluid. As indicatedpreviously, this reduces the risk of gas embolism for the donor but alsorapidly fills the tubes for analysis of the blood collected.

[0044] In addition, because the length of the second tube 11 situatedinside the sampling bag 7 is reduced, the volume of air contained in bag7 before donation begins is also reduced. Because the volume of gas isan essential parameter in the appearance of a gas embolism, the risk ofgas embolism is considerably reduced thereby.

[0045] Table 1 shows the relationship between the volume of gas able tomove through the tube 11 as far as the vein of the donor and the lengthof the portion of tube 11 extending within sampling bag 7. TABLE 1Correlation of Second Tube Length and Volume of Air Able to Enter Veinof Donor Length Volume Length Volume Length Volume of tube of air oftube of air of tube of air (cm) (ml) (cm) (ml) (cm) (ml) Test N^(o) 1 25 5 8 10 10 Test N^(o) 2 2 6 5 8 10 11 Test N^(o) 3 2 6 5 8 10 11 TestN^(o) 4 2 5 5 8 10 11 Mean 2 5.5 5 8 10 10.75

[0046] The lengths of tube used in this test (2, 5 and 10 cm) correspondrespectively to a percentage of 19, 48 and 95% with respect to thelength of the bag 7 used in these tests.

[0047] The characteristics of this bag 7 were as follows:

[0048] length: 10.5 cm;

[0049] width: 5 cm;

[0050] volume: 40 ml.

[0051] In order to avoid the drawbacks arising when the tube 11 does notenter or enters very little within the sample bag 7, while stilllimiting the volume of air contained in the bag 7, it is preferable forthe end part of the second tube 11 to extend inside the sampling bag 7over a distance of between 25% and 60% of the distance between thebottom 8 and the introduction side 9 of the internal volume of thesampling bag 7.

[0052] Thus the invention considerably limits the risks of gas embolismwhatever the preferred position in which the sampling bag 7 is used,particularly in the embodiments shown in FIGS. 1 and 2. Additionally, bylimiting the volume of air able to enter the vein of the donor,embodiments of the present invention may decrease the amount of harm tothe donor should an embolism occur.

[0053] Although the present invention and its advantages have beendescribed in detail, it should be understood that various changes,substitutions and alterations can be made herein without departing fromthe spirit and scope of the invention as defined by the followingclaims.

1. A bag system for collecting and sampling a biological fluid from adonor comprising: a collection bag for collecting the biological fluid;a first tube connected at a first end to a collection means and at asecond end to the collection bag; a flexible sampling bag defining aninternal volume, the internal volume having a bottom side and anintroduction side having an inlet orifice; and a second tube having afirst end connected to the first tube and a second end inserted into theinlet orifice of the sampling bag, wherein the second end of the secondtube extends into the internal volume of the sampling bag over adistance between 25% and 60% of the distance between the bottom side andthe introduction side of the internal volume.
 2. The bag system of claim1, wherein the second end of the second tube extends into the internalvolume of the sampling bag over a distance between 30% and 50% of thedistance between the bottom side and the introduction side of theinternal volume.
 3. The bag system of claim 1, further comprising alateral sampling device connected to the second tube outside of thesampling bag and operable to allow the collection of biological fluidsamples from the sampling bag.
 4. The bag system of claim 1, wherein thebiological fluid comprises blood or a blood component.
 5. The bag systemof claim 4, further comprising the system operable to reduce the risk ofembolism to the donor during donation of the blood or blood component.6. The bag system of claim 1, wherein the bag system comprises a closedcircuit.
 7. A bag system for collecting and sampling a biological fluidfrom a donor comprising: a collection bag for collecting the biologicalfluid; a first tube connected at a first end to a collection means andat a second end to the collection bag; a flexible sampling bag definingan internal volume, the internal volume having a bottom side and anintroduction side having an inlet orifice; a second tube having a firstend connected to the first tube and a second end inserted into the inletorifice of the sampling bag, wherein the second end of the second tubeextends into the internal volume of the sampling bag over a distancebetween 25% and 60% of the distance between the bottom side and theintroduction side of the internal volume; a satellite bag system; and atleast one satellite tube connected at a first end to the satellite bagsystem and connected at a second end to the collecting bag.
 8. The bagsystem of claim 7, wherein the satellite bag system comprises: at leasttwo bags; and a filtration unit.
 9. The bag system of claim 7, whereinthe second end of the second tube extends into the internal volume ofthe sampling bag over a distance between 30% and 50% of the distancebetween the bottom side and the introduction side of the internalvolume.
 10. The bag system of claim 7, further comprising a lateralsampling device connected to the second tube outside of the sampling bagand operable to allow the collection of biological fluid samples fromthe sampling bag.
 11. The bag system of claim 7, wherein the biologicalfluid comprises blood or a blood component.
 12. The bag system of claim11, further comprising the system operable to reduce the risk ofembolism to the donor during donation of the blood or blood component.13. The bag system of claim 7, wherein the bag system comprises a closedcircuit.